MAUDE Adverse Event Report: ARTHREX, INC. 3.0X130MM FIBULA NAIL, LEFT; INTRAMED FIXATN ROD AND ACCESS

Model Number	3.0X130MM FIBULA NAIL, LEFT
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via (b)(4) that an ar-8973l-30-130 arthrex fibulock nail was not working properly; the talons that open on the tip would not deploy once in the patient.Another new ar-8973l-30-130 arthrex fibulock nail was used to complete the case.This was discovered during a procedure, with no reported patient harm.Additional information was received on 08/01/2024: this was discovered during a fibulock (fibula fracture) procedure on (b)(6) 2024.The case was not delayed and was completed by opening a new implant.There were no adverse effects on the patient due to this issue.
Additional Manufacturer Narrative
Addl info: d4, g3.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.However, the allegation that this happened upon opening the box cannot be verified as the device had signs of usage.One unpackaged, ar-8973l-30-130, arthrex® fibulock® nail, batch 15070715, was received for investigation.Visual evaluation noted that the nail talons had been actuated.Additionally, along the shaft down to the nose, deep abrasion marks were noted along it.Functional testing was performed and resistance was noted when opening and closing the talons.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• Brand Name: 3.0X130MM FIBULA NAIL, LEFT
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19972813
• Report Number: 1220246-2024-07157
• Device Sequence Number: 17883453
• Product Code: HSB
• UDI-Device Identifier: 00888867295209
• UDI-Public: 00888867295209
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K173656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3.0X130MM FIBULA NAIL, LEFT
• Device Catalogue Number: AR-8973L-30-130
• Device Lot Number: 15070715
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 11/07/2024; 01/07/2025
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 12/05/2024; 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown